Research & Biotechnology

1. For investigator-initiated research studies:
    

   	TYPES OF RESEARCH PROPOSAL
   LIST OF REQUIREMENTS	Clinical Research Proposal (Research with human participants)	Databank Research Proposal	Non-human Basic Research Projects (e.g. Laboratory, Animal, or Plant studies)	Case Report and Interesting Cases	Systematic review and Meta-analysis	Thesis and Dissertations
   1. Endorsement letters from the Institute/Department Research Committee Head noted by the Institute/Department Head addressed to: ISRC Chair-Dr. Noel D. Atienza for SLMC- QC or ISRC Chair-Dr. Maria Teresa S. Tolosa for SLMC- GC and IERC Chair-Dr. Gelza Mae Zabat for SLMC- QC and GC and IBRCR Chair-Dr. Ann Florence V. Belvis (If involving handling of hazardous materials in laboratory) IACUC Chair-Dr. Blanquita B. de Guzman (If animal study)	✅	✅	✅ For ISRC, IBRCR and AICUC only	✅	✅	✅
   2. Institute/Department Research Committee approved research proposal in R&B Forms: Form 1A Clinical Research Proposal Template for research with human participants Form 1B Clinical Databank Proposal Template for databank/registry proposal Form 1C Basic Science Research Template Form 1D Case Report Proposal Template Form 1E Systematic review and Meta-analysis Proposal Template Form 1F Proposal template for Scientific Procedures Using Animals in letter size with PROTOCOL VERSION AND DATE in the lower left footnote as seen on the template	✅ Form 1A	✅ Form 1B	✅ Form 1C or Form 1F	✅ Form 1D	✅ Form 1E	✅
   3. Data collection forms in leter size with PROTOCOL VERSION AND DATE in the lower left footnote as seen on the template	✅	✅	✅	✅
   4. Informed Consent Form (ICF) if applicable (English and Filipino) in letter size with PROTOCOL VERSION AND DATE in the lower left footnote (Filipino version is notneeded if the participants are professionals.)	✅	✅		✅		✅
   5. Budget Proposal Form (please be advised that the budget being cited in the budget proposal form, is the budget that will be requested from the Research and Biotechnology Group. If no budget will be requested, you are still required to submit the budget proposal form and indicate "no funds will be requested")	✅	✅	✅			✅
   6. Curriculum Vitae (CV) of all Study Team members (with date and signature)	✅	✅	✅	✅	✅	✅
   7. Valid Good Clinical Practice (GCP) certificate of all Study Team members (GCP certificate is valid for 3 years only)	✅	✅		✅		✅
   8. Disclosure of Conflict of Interest (COI) Form of all Study team members	✅	✅	✅	✅		✅
   9. IERC Initial Submission Checklist	✅	✅	✅	✅	✅	✅
   10. Technical Review Form/s signed and dated by Research Committee Revie wer/s who are not part of the study team/proponents	✅	✅	✅
   11. Thesis/Dissertation Approval from the school Thesis/Dissertation Committee						✅
   12. School’s IRB Approval, if applicable						✅
   13. Complete approved research protocol						✅
   14. Certification from the school that SLMC will be acknowledged in the manuscript, future publications and oral or poster presentations upon approval of the head for R&B						✅
   15. Biosafety Clearance Application Form			✅			✅
   16. Biosafety Risk Assessment Form			✅			✅
   For submission: Please send all soft copies of the required documents listed above based on your research proposal (in a .pdf file) to scientificreview.qc@stlukes.com.ph or you may call 8723-0101 local 4734 for more questions or clarifications. Thank you.



2. For sponsor-initiated clinical trials, human research studies:
   • Letter of intent addressed to SL-IERC Chair
   • Soft copy of the Protocol with the following attachments:
     - Informed Consent Forms (English and Filipino)

     The mobile number of the Principal Investigator should be included in the ICF, Patient card and Patient Diary aside from the clinic’s phone number.

     - Informed Consent Process
     - Subject Recruitment Process
     - Case Report Forms
     - Investigator’s Brochure
     - Disclosure of Conflict of Interest
     - Initial Submission Sheet for Clinical Trial
     - Initial Protocol Review Acknowledgement Form
     - Pharmacokinetics (If applicable)
     - Subject Worksheets/Patient Diary/Alert Cards (English and Tagalog versions
     - Questionnaires (English and Tagalog Versions)
     - Philippine Food and Drug Administration Approval
     - Certificate of Product Registration in the Philippines for Postmarketing Surveillance Studies (PMSS)
     - Curriculum Vitae of Investigators and study team members
     - GCP Certificates of Investigators and study team members
     - PRC License of Investigators and Sub-Investigators
     - Delegation of Authority from the Sponsor
     - Certificate of Insurance and a copy of the policy
     - License to Operate (LTO) to conduct a clinical trial
     - Other related study materials

    

For initial submission of sponsor-initiated clinical trials:

Review fees

Schedule of IERC Meetings

IERC Budget

IERC SOP Manual

List of approved protocols

List of ongoing clinical trials

Guidelines on the conduct of ethical research